A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis

Psoriasis Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Chinese Subjects With Moderate to Severe Plaque-type Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008995
• Other study ID #: CR016318
• Secondary ID: C0743T23CR016318
• Status: Completed
• Phase: Phase 3
• First received: November 5, 2009
• Last updated: October 17, 2013
• Start date: October 2009
• Est. completion date: July 2011

Study information

• Verified date: October 2013
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of HealthChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy (good or bad effects) and safety of ustekinumab in the treatment of patients with moderate to severe psoriasis in China.

Description:

In this study, 220 patients will be divided into two groups randomly (by chance), like flipping a coin. Each group will receive a different treatment. The results for each group are compared to each other. There are 2 treatment groups in this study, Group 1 and Group 2. Group 1 will receive placebo at Weeks 0 and 4, ustekinumab 45 mg at Weeks 12 and 16. Group 2 will receive ustekinumab 45 mg at Weeks 0, 4, and 16 and placebo at Week 12. All patients in the study will eventually receive ustekinumab after Week 12. The patients will be in the study for about 36 weeks, with study visit approximately 10 times. Effectiveness evaluations will be conducted throughout the study and include the Psoriasis Area and Severity Index (PASI), Physician's Global Assessment (PGA) and Dermatology Life Quality Index (DLQI). Safety assessments will also be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure) and the occurrence and severity of adverse events. GROUP 1: Placebo at Weeks 0 and 4, ustekinumab 45 mg at Weeks 12 and 16. GROUP 2: Ustekinumab 45 mg at Weeks 0, 4, and 16. Placebo at Week 12

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be of Chinese ancestry

• Have had a diagnosis of plaque-type psoriasis at least 6 months prior to study start

• Have plaque-type psoriasis covering at least 10% of total BSA at screening and at the time of study start

• Have a Psoriasis Area and Severity Index (PASI) score of 12 or greater at study start

• Must be candidates for phototherapy or systemic treatment of psoriasis (either naive or history of previous treatment)

Exclusion Criteria:

• Currently have nonplaque forms of psoriasis

• Have current drug-induced psoriasis

• Have used any investigational drug within the previous 4 weeks

• Have used any biologic within the previous 3 months

• Be known to be infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• placebo
Subcutaneous injection at Week 0 and 4
• ustekinumab
45 mg subcutaneous injection at Week 12 and 16
• placebo
Subcutaneous injection at Week 12
• ustekinumab
45 mg subcutaneous injection at Week 0, 4 and 16

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12.	Scores could range from 0 (mild) to 72 (severe).	Baseline (Week 0) to Week 12	No
Secondary	The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12		Week 12	No
Secondary	The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12.	Scores could range from 0 to 30. A lower DLQI score represents better quality of life.	Baseline (Week 0) to Week 12	No